Hepatitis C Virus Self-testing (HCVST) in Sexual and Gender Minorities in Rio de Janeiro

Summary

Sexual and gender minorities (SGM), such as gay, bisexual and other men who have sex with men (MSM) and transgender women (TGW), are at high risk of HCV infection. A recently released guideline by the WHO recommended HCVST to scale-up HCV screening. However, data on delivery-services of HCVST kits and uptake of HCV testing using HCVST remain scarce in Latin American countries. Additionally, data on the usability of HCVST in MSM/TGW, especially blood-based tests, still lacking in Brazil. To evaluate the uptake of HCV testing by the strategy of using HCVST ordered by the internet and delivery by the post in key populations (SGM) living in the metropolitan region of Rio de Janeiro (Brazil). Additionally, an Ancillary study will assess the usability of different kits of HCVST in MSM/TGW using PrEP.

Study Design and Population: This protocol will be composed of two studies that will be conducted in parallel. The primary study will be a cohort study in which SGM ≥ 18 years old living in the metropolitan area of Rio de Janeiro who request HCVST will be included. The Ancillary study will be a cross-sectional study where adult MSM or TGW attending a presential visit for PrEP (initiation or follow-up) at INI/FIOCRUZ will be eligible for this study. The investigators estimate that 3,000 persons will request home-delivery of HCVST (Primary study) and 250 participants will be included in the Ancillary study.Study Design and Population: This protocol will be composed of two studies that will be conducted in parallel. The primary study will be a cohort study in which SGM ≥ 18 years old living in the metropolitan area of Rio de Janeiro who request HCVST will be included. The Ancillary study will be a cross-sectional study where adult MSM or TGW attending a presential visit for PrEP (initiation or follow-up) at INI/FIOCRUZ will be eligible for this study. The investigators estimate that 3,000 persons will request home-delivery of HCVST (Primary study) and 250 participants will be included in the Ancillary study.

Methods: For the Primary Study, a web-based platform will be built for this project and an educational campaign will be developed in dating apps to encourage HCV testing. The web platform will contain modules with information on HCV infection and a log-in to request HCV self-tests that can be delivered by the post or collected in the centralized pharmacy for HCV testing. People will be encouraged to report their HCVST results in the online platform. People with positive HCV antibody will be linked-to-care for HCV infection confirmation and treatment initiation. For the Ancillary Study, MSM/TGW attending presential visits for PrEP at INI/FIOCRUZ will be invited to perform HCVST (blood-based and oral fluid tests) under supervision of a trained healthcare worker. Participants will read written instructions and watch a video explaining the procedures step-by-step for HCVST. A second HCV test using the same kit will be performed by the healthcare worker for concordance analysis. People with positive HCV antibodies will be linked to HCV infection confirmation and treatment initiation.

Data analysis: Descriptive statistical analysis will be used to evaluate the characteristics of people seeking HCVST, participant's preferences, uptake of HCV testing using self-test kits and internet technologies, as well as acceptability, usability and result interpretation of HCVST in a sub-sample of participants. Ethical considerations: Locally, ethics approval will be obtained from the INI/FIOCRUZ. International ethics clearance will be obtained from the World Health Organization Ethics Review Committee (WHO ERC). All participants will be informed of risks and benefits of the procedures and that their participation is voluntary. All participants will be required to sign the informed consent (an online agreement for Primary Study) as required by Brazilian regulations to participate in research studies. All data collected will respect The Brazilian General Data Protection Law (Law nº 13.709/2018).

Conditions

• Hepatitis C

Interventions

DIAGNOSTIC_TEST

Hepatitis C virus self-test (oral fluid HCVST)

The participant will be able to choose between oral-fluid or blood-based HCVST. The package will include an HCV OraQuick ® HCV Self-Test kit, (OraSure Technologies, Inc, Bethlehem, PA) or a Wondfo® HCV Self-Test (Guangzhou, P.R. China) at Primary Study. At Ancyllary study, the individuals attending PrEP consultations at INI/FIOCRUZ will be invited to perform HCVST using blood-based and oral-fluid kits.

DIAGNOSTIC_TEST

Hepatitis C virus self-test (blood-based HCVST)

The participant will be able to choose between oral-fluid or blood-based HCVST. The package will include an HCV OraQuick ® HCV Self-Test kit, (OraSure Technologies, Inc, Bethlehem, PA) or a Wondfo® HCV Self-Test (Guangzhou, P.R. China) at Primary Study. At Ancylary Study, the individuals attending PrEP consultations at INI/FIOCRUZ will be invited to perform HCVST using blood-based and oral-fluid kits.

Sponsors & Collaborators

• World Health Organization

  collaborator OTHER

• UNITAID

  collaborator OTHER

• Oswaldo Cruz Foundation

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-08

Primary Completion

2025-12-31

Completion

2025-12-31

FDA Device

Yes

Countries

• Brazil

Study Locations